A consensus rating method for small virus-retentive filters. II. Method evaluation.

Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.

A consensus rating method for small virus-retentive filters. I. Method development.

Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.

PDA Virus Filter Task Force update.

The PDA Virus Filter Task Force has made significant progress in producing a method that will standardize the nomenclature for virus-removal filters that remove large viruses. A method for preparation of the model bacteriophage, PR 772, has also been produced and will shortly undergo a feasibility study. A technical report on the use of virus removal filters is also being prepared.

Current issues in validation of chromatography.

Chromatography has now been used successfully for more than 20 years to provide the requisite purity for biologicals, but there remain some issues of concern. These issues include carryover and cleaning validation, potential for contamination by microorganisms, potential leachables, and resin lifespan. Compounding these issues is the fact that chromatography media have a very large surface area, and it is not always clear what is occurring at the surface.

Preparative chromatographic separations in pharmaceutical, diagnostic, and biotechnology industries: current and future trends.

Chromatography is widely employed in industry for the purification of biotherapeutics and diagnostics. Regulatory requirements dictate that the chromatographic process be reproducible and provide the necessary product purity. Current trends in designing and implementing purification strategies take into consideration the requirements for both chromatography media and equipment.

Validation of biotechnology products and processes.

Recent advances in the validation of biotechnology products have focused on clearer definitions of the requirements for cleaning validation, especially for multi-product facilities. In addition, sensitive analytical methods have been developed that can be validated. This, together with computer validation, has contributed to the biotechnology industry's ability to demonstrate the production of safe and efficacious products for biotherapeutic and diagnostic purposes.